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Inclusion of Children - Policy Implementation

NIH Inclusion of Children as Participants in Research Involving Human Subjects

This covers the NIH policies and procedures on the inclusion of children as participants in research involving human subjects.

NIH policy requires that applicants and grantees include children when conducting clinical research, unless there is a strong justification for their exclusion.

For information about the protection of children as human subjects: go here.

Latest Updates on the Inclusion of Children

The NIH's Definition of Children to Change
The NIH has issued Guide Notice NOT-OD-16-010 "Inclusion of Children in Clinical Research: Change in NIH Definition". Starting with applications/proposals submitted for due dates on or after January 25, 2016, for the purposes of inclusion policy, the age of a child will be defined as individuals under 18 years old instead of under 21 years old, the current NIH definition of a child for inclusion policy considerations.

Applicants/offerors for NIH funding will still be expected to justify the age range of the proposed participants in their clinical research, with particular attention paid to addressing the inclusion (or exclusion) of children (or subsets of children).  However, now that threshold applies to individuals under the age of 18 rather than under the age of 21.


Sections:


Policy References

Title Description Link Original Posting Date
NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects NIH Guide Notice. The goal of this policy is to increase the participation of children in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may also affect children. Website 03/06/1998
Decision Tree for Participation of Children in Research This is a tool for deciding if the inclusion of children is appropriate for a specific study. It is an attachment to the 03/06/98 NIH Guide shown above. Website 03/06/1998
 

FAQs and Other Resources

Title Description Link Original Posting Date
FAQ on the Inclusion of Children as Participants in Research Involving Human Subjects Questions and Answers about the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research involving Human Subjects. Website 03/17/1999
Inclusion of Children Case Studies (SCIENTIFIC)
 
Case Studies have been developed to assist Investigators in evaluating when children should be included in research studies supported by the NIH. Website


Word
03/26/1999

 

Related Guide Notices

Notice Number Guide Notice Title Notice Description Link Original Posting Date
NOT-OD-16-010

Inclusion of Children in Clinical Research: Change in NIH Definition (NOT-OD-16-010)

[National Institutes of Health]

This guide notice informs NIH applicants and grantees/contractors about a change related to the NIH policy on the inclusion of children in clinical research.

The age of a child has been redefined for the purposes of inclusion policy and will be defined as individuals under 18 years old.

Website 10/16/2015
NOT-OD-16-004

NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications
(NOT-OD-16-004)

[National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality(AHRQ)]

This guide notice informs the biomedical and health services research communities of planned changes to policies, forms and instructions for grant applications submitted in 2016.

Inclusion reporting is one of the areas where changes will take place.

Website 10/16/2015
NOT-OD-16-005

NIH Announces Upcoming Changes to Post-Award Forms and Instructions
(NOT-OD-16-005)

[National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ)]

This guide notice informs the biomedical and health services research communities of planned changes to policies, forms and instructions for interim and final progress reports, and other post-award documents associated the monitoring, oversight, and closeout of an award. Website 10/16/2015